EP1887970A2 - A prostatic stent and a detachable catheter apparatus comprising the same - Google Patents
A prostatic stent and a detachable catheter apparatus comprising the sameInfo
- Publication number
- EP1887970A2 EP1887970A2 EP06755901A EP06755901A EP1887970A2 EP 1887970 A2 EP1887970 A2 EP 1887970A2 EP 06755901 A EP06755901 A EP 06755901A EP 06755901 A EP06755901 A EP 06755901A EP 1887970 A2 EP1887970 A2 EP 1887970A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- tube section
- distal
- proximal
- catheter apparatus
- expandable member
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
Definitions
- a prostatic stent and a detachable catheter apparatus comprising the same
- the present invention concerns a prostatic stent and a detachable catheter apparatus comprising the same, as generally described in US patent 5 876 417, the content of which is hereby incorporated by reference.
- a prostatic stent consisting of a tube assembly
- This tube assembly comprises a distal tube section having a closed distal end and a proximal opened part, said distal end including at least one orifice to enable urine from the bladder to enter the distal tube section and to flow into and through the distal tube section, across connection means and through said sphincter; a proximal tube section having a distal part and a proximal end; and connection means connecting the proximal part of said distal tube section and the distal part of said proximal tube section together.
- the tube assembly of the prostatic stent makes part of a detachable catheter apparatus extending along a longitudinal axis
- said detachable catheter comprising: a) a tube assembly being the prostatic stent, b) an insertion device slidably receivable into said tube assembly, said insertion device comprising an elongated inner alignment rod having a contact distal end and an insertion proximal end portion, said rod being longitudinally sized to extend into the tube assembly wherein the contact distal end contacts the closed distal end of said distal tube section while the proximal end portion projects outwardly from said tube assembly; and an outer pusher tube having a bore longitudinally therethrough and sized to slidably receive said alignment rod, c) an expandable member disposed circumferentially about and longitudinally along the distal part of said proxi
- the expandable member is an inflatable balloon localized on the outer surface of the proximal tube section
- the expandable member is a Malecot arrangement comprising tongues, each tongue being foldable between two positions, namely a first position folded outwards at its centre and an unfolded position in which it is included in the wall of the proximal tube section.
- Both embodiments are insufficient to reproduce regularly correct positioning of the stent in the prostatic urethra.
- the lower tube section of the stent was pushed above the sphincter.
- the abutment of the Malecot or of the inflated balloon against the external sphincter was not clearly perceived by the operator.
- the stent had to be reinserted and positioned under the control of endoscopy or transrectal ultrasonography. Upwardss and downwardss migration of the urethral stent were observed.
- One object of the present invention is to propose an endo- prostatic stent and a detachable catheter apparatus including the same, to allow the correct positioning of the stent using tactile feed-back of the operator during insertion i.e. without the need for any imaging means like endoscopy or sonography.
- Another object of the present invention is to decrease the risk of migration of the endo-prostatic stent, once inserted in the urethra and the bladder.
- said expandable member disposed on said proximal tube section is arranged to abut permanently in said expanded state against said sphincter and to oppose any upward movement in said urethra of said catheter apparatus
- said catheter apparatus comprises another expandable member disposed circumferentially about and longitudinally along the proximal part of said distal tube section, said another expandable member being arranged to be self working between a collapsed state, when said catheter apparatus moves upwards in said urethra towards the bladder, and an expanded state permitted by said urethra and opposing to any downward movement of said catheter apparatus.
- said distal part of said proximal tube section consists of said expandable member which comprises flexible tongues distributed about said proximal tube section, each of said tongues being arranged to be elastically biased towards a radial and outward position, and said expansion and/or collapse controlling means comprise a sheath adapted to enclose said distal part of said proximal tube section and constrain all tongues in a collapsed position lying in the longitudinal direction of said catheter apparatus; as an example, in said radial and outward position, each tongue extends obliquely with respect to the longitudinal axis towards the distal end of said catheter apparatus.
- said another expandable member comprises flexible tongues distributed about said distal tube section, each of said tongues being arranged to be elastically biased towards a radial and outward position; as an example, in said radial and outward position, each tongue extends obliquely with respect to the longitudinal axis towards the proximal end of said catheter apparatus.
- said connecting means of said tube assembly connect a proximal end of said distal tube section adjacent to said another expandable member, and a distal portion of said proximal tube section adjacent to said expandable member; as an example said connecting means comprises threads distributed about the longitudinal axis of said catheter apparatus, attached on opposite ends respectively to said proximal end of said distal tube and said distal portion of said proximal tube section.
- correct positioning of the urethra stent is obtained by the tactile feedback of the abutment of the expandable member of the proximal tube section against the urinary sphincter. And where another expandable member is disposed on said distal tube section, migration of the stent in any direction (upward and/or downward) is prevented.
- Figure 1 is a schematical elevation view of a detachable catheter apparatus according to the present invention, including a prostatic stent still according to the present invention.
- FIG. 2 still in a schematical manner, shows the insertion of an invention prostatic stent through the urethral meatus, with a detachable catheter apparatus according to the present invention.
- FIG. 3 shows the insertion of a detachable catheter apparatus according to the present invention, during its insertion into its final position in the urethra and bladder.
- This figure shows also a schematic representation of the anatomy of the urinary system of a male living being.
- FIG. 4 still in a schematical manner, shows the invention prostatic stent in its final position in the urethra and bladder, once the other parts of the detachable catheter apparatus have been successively extracted from the urethra.
- the invention prostatic stent is made of a tube assembly comprising a proximal tube section 1 and a distal tube section 2 linked by a flexible connecting means 3.
- a proximal end (the part on the opposite side of the sphincter) has a tubular shape
- a distal part 4 (the part on the side of the sphincter) has a half Malecot design, i.e. with tongues 21 .
- Said distal part has a tubular shape when, tongues 21 are flattened inside an outer sheath 6 gliding along the tube assembly. Same distal part has an umbrella shape when the tongues 21 are spread, as soon as the outer sheath 6 glides outside and allows spreading of the tongues.
- the degree of their opening adapts automatically to the variable diameter of the urethra during progression of the stent inside the urethra lumen. Maximum opening is observed at the level of the bulbous urethra 12, where urethra diameter is the largest, just below the urinary sphincter. Once the stent is in correct position the opened tongues abut against the lower side of the sphincter preventing from upward migration.
- the distal tube section 2 has another expandable member 5 with a half part Malecot design.
- the latter differs from the one of the proximal tube section 1 in that:
- the orientation of the free tips of the tongues 22 is the opposite of the one of the tongues 21 of the half-Malecot of the proximal tube section, so that the tips of each half-Malecot look at each other.
- the tongues of the half-Malecot of the distal tube section tend to flatten during insertion of the stent, whereas they spread at the level of the veru montanum as soon as the stent is in position. The latter prevent the stent from downward migration.
- the distal tube section has two orifices 9 at the level of its distal end to drain urine out of the bladder.
- the distal end is closed and smooth.
- the inner diameter of the proximal and distal tube sections allows the insertion of an elongated inner alignment rod.
- the flexible connecting means 3 is a first flexible connecting means 3:
- a single or several non resorbable sutures, or a sleeve, or the association of suture plus sleeve can be used for the connecting means 3.
- the sleeve can be permanent or resorbable. In the latter case, permanent connection is assured by one or several non resorbable sutures after the resorption of the sleeve.
- the outer sheath 6 is a tube with:
- - a very thin wall, so that the difference in size between the external diameter of the stent and the one of the outer sheath will not be felt during insertion through the meatus of the urethra; - a hollow plate 61 located at its proximal end. This plate abuts against the meatus of the urethra during insertion of the stent.
- the pusher tube 7 is a tube with:
- the total length of the stent plus the one of the pusher tube is longer than the length of the male urethra
- the outer diameter is the same as the one of the stent
- the alignment rod is a flexible cylinder. It allows the alignment of the stent and of the pusher tube.
- the length of the rod is the sum of the length of the stent plus the one of the pusher tube. The distal end of the rod abuts against the closed or blind distal end of the distal tube section of the stent.
- the procedure for inserting a prostatic stent according to the present invention is now described with references to figure 2.
- the stent is delivered with the two tube sections 1 and 2 and the pusher tube 7 mounted on the rod 8, and with the outer sheath 6 mounted on the pusher tube.
- the tongues 21 and 22 of the two expandable members 4 and 5 are spread.
- the outer sheath is moved upwards from its position on the pusher tube to the position where the tongues of both tube sections 1 and 2 are flattened.
- the operator holds the pusher tube 7 at the level of the junction with the plate 61 of the outer sheath 6 to secure it in the latter position.
- the stent is inserted in the urethra until the plate 61 of the outer sheath 6 abuts against the meatus.
- the pusher tube 7 is inserted through the outer sheath 6 until the distal end of the stent abuts the urinary sphincter 13.
- the stent is pushed through the sphincter until the tongues 21 of the proximal tube section spread in the bulbous urethra 12 and stop insertion as they bump against the lower side of the sphincter.
- the stent is in correct position inside the prostate 16; the distal tube section is inside the prostatic urethra 14, the tongues 22 of its proximal part are spread at the level of the veru montanum 15, the connecting means 3 are at the level of the sphincter and the proximal tube section is located in the bulbous urethra with the tongues 21 of the distal part spread below the sphincter.
- the orifice 9 at the distal end of the distal tube section is inside the bladder 17 for urine drainage.
- the stent is in correct position: the tongues of the expandable member 4 of the proximal tube section abut against the lower side of the sphincter, the connecting means is positioned through the sphincter, and the distal tube section is in the prostatic urethra.
- the tongues of the expandable member of the distal tube section are spread at the level of the veru montanum.
- the orifice 9 of the distal end of the stent is in the bladder.
- the stent stays in place by itself (Fig. 4): prevention of upward migration is assured by the tongues 21 spread inside the bulbous urethra, prevention of downward migration is assured by the tongues 22 spread at the level of the veru montanum.
- the flexible connection means allows normal functioning of the sphincter.
- the rod 8, pusher tube 7 and outer sheath 6 have been successively extracted.
- the sphincter is closed over the flexible connecting means 3.
- the tongues of the two expandable members maintain the correct position of the two tube sections of the stent on both sides of the sphincter. Urine can flow through the two tube sections when the sphincter opens up.
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US68329805P | 2005-05-23 | 2005-05-23 | |
PCT/IB2006/001343 WO2006126060A2 (en) | 2005-05-23 | 2006-05-23 | A prostatic stent and a detachable catheter apparatus comprising the same |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1887970A2 true EP1887970A2 (en) | 2008-02-20 |
EP1887970B1 EP1887970B1 (en) | 2016-04-20 |
Family
ID=37452406
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP06755901.3A Active EP1887970B1 (en) | 2005-05-23 | 2006-05-23 | A prostatic stent and a detachable catheter apparatus comprising the same |
Country Status (6)
Country | Link |
---|---|
US (1) | US8070825B2 (en) |
EP (1) | EP1887970B1 (en) |
JP (1) | JP5038298B2 (en) |
CA (1) | CA2609372A1 (en) |
ES (1) | ES2575540T3 (en) |
WO (1) | WO2006126060A2 (en) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2582203T3 (en) | 2007-05-16 | 2016-09-09 | Marian Devonec | Device for stent positioning |
US9387312B2 (en) | 2008-09-15 | 2016-07-12 | Brightwater Medical, Inc. | Convertible nephroureteral catheter |
US9956100B2 (en) | 2009-09-15 | 2018-05-01 | Brightwater Medical, Inc. | Systems and methods for coupling and decoupling a catheter |
US9750621B2 (en) * | 2012-06-08 | 2017-09-05 | University Hospitals Cleveland Medical Center | Ureteral stent for placement in a kidney and bladder |
EP3179958B1 (en) | 2014-08-12 | 2021-10-20 | Merit Medical Systems, Inc. | Systems for coupling and decoupling a catheter |
WO2017192145A1 (en) | 2016-05-06 | 2017-11-09 | University Hospitals Health Systems, Inc. | Ureteral stent |
JP2019063475A (en) * | 2017-10-03 | 2019-04-25 | 株式会社岡田快適生活研究所 | Urethra indwelling implement |
JP7044239B2 (en) * | 2017-12-22 | 2022-03-30 | 株式会社岡田快適生活研究所 | Urethral indwelling device |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US238368A (en) * | 1881-03-01 | Wellington | ||
FR2701648B1 (en) | 1993-02-19 | 1995-03-31 | Marian Devonec | Prosthesis intended for the treatment of a light or natural way, in particular endo-urethral prosthesis. |
FR2722413B1 (en) | 1994-07-13 | 1997-02-07 | Marian Devonec | THERAPEUTIC IMPLANT INTENDED FOR THE SELECTIVE CYTOREDUCTIVE TREATMENT OF LIGHT OR NATURAL PATH OBSTRUCTION OF A HUMAN OR ANIMAL BODY |
FR2736554B1 (en) * | 1995-07-10 | 1997-08-29 | Devonec Marian | CATHETER FORM OF A SEPARABLE CATHETERIZATION MEANS AND INTRODUCTION MEANS USEFUL FOR THE TREATMENT OF PROSTATIC OBSTACLES IN MAN |
US7118600B2 (en) * | 1998-08-31 | 2006-10-10 | Wilson-Cook Medical, Inc. | Prosthesis having a sleeve valve |
US7141038B2 (en) | 2000-08-07 | 2006-11-28 | Abbeymoor Medical, Inc. | Endourethral device and method |
WO2002058541A2 (en) * | 2001-01-23 | 2002-08-01 | Abbeymoor Medical, Inc. | Endourethral device & method |
-
2006
- 2006-05-23 EP EP06755901.3A patent/EP1887970B1/en active Active
- 2006-05-23 ES ES06755901.3T patent/ES2575540T3/en active Active
- 2006-05-23 US US11/920,974 patent/US8070825B2/en active Active
- 2006-05-23 CA CA002609372A patent/CA2609372A1/en not_active Abandoned
- 2006-05-23 JP JP2008512938A patent/JP5038298B2/en active Active
- 2006-05-23 WO PCT/IB2006/001343 patent/WO2006126060A2/en active Application Filing
Non-Patent Citations (1)
Title |
---|
See references of WO2006126060A2 * |
Also Published As
Publication number | Publication date |
---|---|
US8070825B2 (en) | 2011-12-06 |
EP1887970B1 (en) | 2016-04-20 |
JP5038298B2 (en) | 2012-10-03 |
WO2006126060A3 (en) | 2007-04-05 |
JP2008541821A (en) | 2008-11-27 |
CA2609372A1 (en) | 2006-11-30 |
US20080234832A1 (en) | 2008-09-25 |
ES2575540T3 (en) | 2016-06-29 |
WO2006126060A2 (en) | 2006-11-30 |
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